510(k) K133811
K133811 is an FDA 510(k) premarket notification submitted by Mako Surgical Corp. for the device "RESTORIS POROUS PARTIAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 8, 2014. The device falls under product code NJD (Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer), a Class II device regulated under 21 CFR 888.3535. Mako Surgical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 2014
- Date Received
- December 16, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3535
- Review Panel
- OR
- Submission Type
Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.